The “Essential Drug”

Throughout the developing world, an opioid is being trafficked freely. Pharmacists call it tramadol; drug dealers call it bouton rouge; and Doctors Without Borders calls it “an essential drug.”

Tramadol has become essential because regulated opioids are unavailable in many developing nations. As Dr. Katherine Pettus, an advocacy officer for the International Association for Hospice and Palliative Care, states, “lack of access to essential medicines such as morphine … violates the right to be free from torture and constitutes cruel and unusual punishment.”

Opioids are necessary for pain relief, but they are also dangerous because of their high potential for abuse. In the United States, overprescription has been one of the main causes of opioid addiction, which has led to predicaments such as the heroin crisis (see feature).[1] As such, lawmakers have written an uneasy balance into opioid legislation. Their efforts are best described by the dual mandate of the International Narcotics Control Board (INCB): “to increase access to controlled substances for medical purposes and to stop their illicit use.”[2]

Unfortunately, this mandate has flaws, and has mainly resulted in providing easier access to opioids for developed countries and extremely limiting restriction to opioids for developing countries, causing many to suffer unnecessarily. In 2011, six developed countries accounted for 79 percent of the global consumption of morphine, whereas developing countries — 80 percent of the world’s population — accounted for a mere six percent of the global consumption of morphine.[3] In developing nations, “opioid-phobia,” the fear that using opioids will necessarily lead to widespread addiction, keeps patients from accessing the few opioids that restrictions allow.

The INCB attempts to control drug use by asking countries to submit forms that detail yearly opioid quotas. These forms are so exhaustive that countries must rely on “sufficient and well-functioning legal systems, State systems, health care and administrative systems” to fill them.[4] As most developing countries’ systems are quite unrefined, developing countries are unable to fill out the forms satisfactorily. Indeed, the INCB wrote 50 countries’ forms in 2011, signaling the forms’ impracticality.[5] Not only are they infeasible, but their foundations are also troubling. Countries with the least resources to combat drug abuse have the highest need for effective international regulations, yet they also have the least resources to satisfactorily fill out the forms that would allow this. Furthermore, countries without ample documentation will receive unreasonably low opioid quotas, since the INCB is more concerned with limiting opioid usage than with providing pain relief.

Afterwards, these estimates must be confirmed by the INCB. Before these are confirmed, patients cannot access opioid analgesics. If a country does not comply with INCB regulations, the INCB can even recommend drug import and export embargoes. The INCB can also prohibit the use of “dangerous” narcotics, even if these are requested for medical use. As such, the INCB controls the type and quantity of licit opioids that reach every country. Its regulatory burdens are so imposing, however, that many developing nations are unable to import regulated drugs. Some developing nations go so far as to ban regulated drugs.

Because of the obvious deficiencies in the regulatory framework, the international community seeks opioids with low abuse potentials.

Enter tramadol. Reports in the mid-1970s described its low abuse potential. Organizations such as the WHO and the INCB viewed it as the perfect solution to imperfect international regulatory frameworks. They left tramadol unregulated, and therefore available to developing countries, because tramadol’s low abuse potential would not lead to an increase in illegal opioid use — or so they believed. Nowadays, some studies characterize tramadol’s abuse potential as comparable to morphine’s. The discrepancy in reports occurred due to tramadol’s strange chemistry: unlike most opioids, it is strongest taken orally, not injected.[6]

This finding is supported by the high abuse levels across the developing world. In Egypt, tramadol is used to bribe officials.[7] In Northern Ireland, tramadol kills more people than heroin.[8] In Northern Cameroon, farmers feed themselves and their cattle tramadol in order to work the long hours.[9] Tramadol’s pervasiveness is especially worrying: not only has a business been built on trafficking tramadol throughout the developing world, but other legitimate businesses are also running on tramadol.

Tramadol is so widely used and abused because it is accessible. It is unregulated and cheap. In Egypt, tramadol consumption increased dramatically after former dictator Hosni Mubarak was deposed, at which point imports were barely inspected. Fortunately, after sentences for smuggling tramadol rose in severity and prices for tramadol increased tenfold (from US$0.15–US$0.3 per pill to US$1–US$3 per pill) the amount of people seeking drug rehabilitation increased dramatically. Nonetheless, many fear that in Egypt, as in the rest of the tramadol-infested world, the worst is yet to come. As tramadol regulation and prices increase, heroin will likely supplant current demand for tramadol.[10]

Other nations that internally regulate tramadol have not had as much luck as Egypt. In Nigeria, for instance, the government confiscates shipments that are not approved by its internal drug control agency. Even so, national legislation is only able to do so much in the face of an internationally unregulated drug. Tramadol exporters have been able to bypass Nigeria’s measures by sending tramadol to Benin, an African country with negligent drug regulations and “the second-largest recipient of registered commercial freight shipments from India of the prescription drug tramadol,” according to the US State Department.[11] This problem would probably be solved with by internationally regulating tramadol.

Tramadol remains unregulated on the World Health Organization’s recommendation. The WHO has consistently refused to review its position on tramadol as a drug with low abuse potential, despite observing “craving, drug-seeking behavior” in some users since 2000.[12] It supports its decision by stating that “data from some countries that have reported abuse and dependence (eg China, Egypt, and Iran,) were missing.”[13] Here, the WHO and the INCB forms share a fallacy. They view the quantity and quality of data from developed and developing countries as equal. This is removed from reality. Developing nations simply do not have the resources to provide the same level of data that developed nations do. The WHO and the INCB should factor this into their decision-making and their forms, as this view has made them dismiss genuine needs and concerns of the third world.

The INCB’s ineffective and burdensome measures prove useless as long as tramadol remains unregulated. Supply of other necessary drugs remains extremely restricted in most developing nations, but economic and personal addictions to tramadol increase. Since governments realize the terrible effects of a rampant, internationally unregulated drug, opioid-phobia increases, leading to lower yearly opioid quotas in developing nations. Furthermore, thanks to the pain relief tramadol does provide, developing nations and the INCB have fewer reasons to increase yearly opioid quotas, even though doing so would lead to less restrictive international regulations that could potentially limit opioid abuse.

 

Works Cited

[1] Elkins, Chris. “Searching for Relief: The Cause of America’s Opioid Epidemic.” Searching for Relief: The Cause of America’s Opioid Epidemic. Accessed July 16, 2017. https://www.drugrehab.com/opioid-epidemic/.

[2]  “The problem of pain,” The Economist, May 28, 2016.

[3] United Nations. World Health Organization. Expert Committee on Drug Dependence. Agenda item 6.1: Tramadol. http://www.who.int/medicines/areas/quality_safety/6_1_EPR_1.pdf.

[4] Gispen, M.E.C. “Poor Access to Pain Treatment: Advancing a Human Right to Pain Relief.” International Federation of Health and Human Rights Organisations.

[5] Taylor, Allyn L. “Addressing the Global Tragedy of Needless Pain: Rethinking the United Nations Single Convention on Narcotic Drugs.” The Journal of Law, Medicine & Ethics 35, no. 4 (2007): 556-70.

[6] Justin Sheck. “Tramadol: The Opioid Crisis for the Rest of the World,” The Wall Street Journal, October 19, 2016.

[7]  “A pill for work and play,” The Economist, April 18, 2015.

[8] Justin Sheck. “Tramadol: The Opioid Crisis for the Rest of the World,” The Wall Street Journal, October 19, 2016.

[9] Justin Sheck. “Tramadol: The Opioid Crisis for the Rest of the World,” The Wall Street Journal, October 19, 2016.

[10]  “A pill for work and play,” The Economist, April 18, 2015.

[11] Justin Sheck. “Tramadol: The Opioid Crisis for the Rest of the World,” The Wall Street Journal, October 19, 2016.

[12] Inveen, Cooper. “Opioids: Sierra Leone’s newest public health emergency.” Opioids: Sierra Leone’s newest public health emergency . February 13, 2017. Accessed August 02, 2017. http://www.aljazeera.com/indepth/features/2017/01/opioids-sierra-leone-newest-public-health-emergency-170119093804569.html.

[13] United Nations. World Health Organization. Expert Committee on Drug Dependence. Agenda item 6.1: Tramadol. http://www.who.int/medicines/areas/quality_safety/6_1_EPR_1.pdf.